Medical skin applicator apparatus

ABSTRACT

A medical skin applicator apparatus includes a fluid housing having a fluid chamber for storing a medical agent and an applicator coupled to the housing. The fluid housing has a penetrable wall to permit access to the fluid chamber and release of the medical agent therefrom. The applicator includes an applicator surface for applying the medical agent to a patient. The applicator has a penetrating member adapted to penetrate the penetrable wall of the fluid housing upon achieving a predetermined coupled relation of the fluid housing and the applicator, to thereby permit the medical agent to be dispensed from the fluid chamber and applied to the patient with the applicator surface.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of provisional application Ser. No.60/599,927, entitled “Skin Applicator”, filed Aug. 9, 2004, andprovisional application Ser. No. 60/614,503, entitled “Skin Applicator”,filed Sep. 30, 2004, and provisional application Ser. No. 60/637,182,entitled “Skin Applicator”, filed Dec. 22, 2004, the entire contents ofeach of these provisional applications being incorporated herein byreference.

BACKGROUND

1. Technical Field

The present disclosure relates generally to medical skin applicators,and more particularly, to a skin applicator apparatus adapted touniformally and consistently dispense sterilizing fluid to a skinsurface of a patient.

2. Description of the Related Art

Many medical procedures involve application of medicines, sterilizingfluids, antiseptics, gels, agents or other materials to portions of thebody, such as the skin, for preparation, treatment, etc. Such medicines,sterilizing fluids, agents are typically transferred to the skin via anapplicator. Conventional liquid applicators incorporate a glass ampouleor plastic blow-molded bottles for storing the liquid and a mechanismfor fracturing the ampoule to release the stored liquid. The releasedliquid contacts a swab, foam pad or tip for application to the skin.

However, numerous problems are encountered with applicators of thistype. Fracture of the glass ampoule generates shards within theapplicator that may pose risks to a patient. Attempts to overcome thesepotential risks include devices that employ screens or foam to containthe glass shards. However, there still exists a possibility ofintroducing these shards into the fluid pathway, which poses anunacceptable and unnecessary risk to the patient.

Another drawback of the above mentioned devices is the permeation ofcertain gases through the seals of bottles as well as the plastic of thebottle. Ethylene oxide (EO) migrates through most plastics at thethicknesses used for blow molding containers (0.040″ or less) and formstoxic by-products when allowed to react with certain antisepticproducts, most notably chlorhexidine gluconate (CHG). Manufacturers havedevised methods to eliminate permeation such as packaging in glassampoules or by employing plastics with gas barrier properties such aspolyethylene terephthalate (PET). PET greatly reduces permeation when asufficient cross-section is provided in the package; however the currentdevices employ blow molded containers in combination with conventionalcaps. The caps therefore become the weakest part of these systems andoftentimes leak due to inconsistent sealings (PET/foil) or due to caploosening due to the pressure imparted during the EO sterilizationprocess.

The current devices mentioned above employ either a glass blow or moldedplastic container with a thickness of or less than 0.030″. This minimalthickness allows for considerable permeation of EO through the wall ofthe container during sterilization. Additionally, the current devicesuse blow-molded containers that during manufacture are pinched off atthe openings or cut via a spindle and knife apparatus. The result is asharp, uneven and irregular top surface to the container, which isproblematic when a seal is applied to the non-uniform surface and anirregular seal is formed.

Additionally, current container designs utilize conventional, singleweld innerseals as a means of sealing the bottle contents. The size ofthe bottle cap and force with which it is tightened on the bottletherefore becomes critical to maintenance of the force needed tomechanically reinforce the foil over time. The loosening of the cap is acommon failure and oftentimes results in leakage of the bottlecontents—especially when the system is pressurized or is required toremain in storage for long periods prior to use.

Finally current devices suffer from control of the contained fluid dueto their design. Ampulized applicators rely upon low viscosity fluid ofless than 200 centipoise due to the small orifice associated with theampule after fracture. Fluids of higher viscosity do not readily flowout of standard ampule designs when inverted. These lower viscosityfluids however require metering features within the applicator,especially when smaller (less than 4 sq. in.) sponges are used.Inevitably these lower viscosity fluids result in loss of fluid controlonce dispensed to the patient's skin which poses an unnecessary risk offire due to the associated pooling of alcohol within surgical drapes.

Alternate embodiments have attempted to address this issue by adding gelcomponents into the antiseptic resulting in a 100 fold increase in theviscosity (2,000 centipoise) or higher. These devices suffer aninability of the fluid to migrate to the sponge dispensing means.

Therefore it would be highly desirable to overcome these disadvantagesrelating to fluid control and viscosity with a device that contained anantiseptic that would flow readily under gravity (400-700 centipoise)thereby eliminating the need for compression of the handle element incombination with an absorbent member, e.g., sponge design, thatcontained sufficient fluid capacity such that little to no pooling ofthe antiseptic fluid would result.

Therefore, it would be desirable to overcome the disadvantages anddrawbacks of the prior art with a medical skin applicator including afluid container having a penetrable surface that is engageable with apiercing member to facilitate fluid communication with a dispensingmember of the skin applicator thereby enabling preparation and treatmentof a skin surface of a patient. It would be desirable if the skinapplicator can be disposed in an inverted orientation during use. Such askin applicator may also accommodate multiple combinations ofsterilizing agents and applicator head designs. It would be highlydesirable if the medical skin applicator and its constituent parts areeasily and efficiently manufactured and assembled.

SUMMARY

In accordance with a preferred embodiment of the present disclosure, amedical skin applicator apparatus includes a fluid housing having afluid chamber for storing a medical agent, and a penetrable wall topermit access to the fluid chamber and release of the medical agenttherefrom, and an applicator coupled to the fluid housing. Theapplicator includes an applicator surface for applying the medical agentto a patient. The applicator has a penetrating member adapted topenetrate the penetrable wall of the fluid housing upon achieving apredetermined coupled relation of the fluid housing and the applicator,to thereby permit the medical agent to be dispensed from the fluidchamber and applied to the patient with the applicator surface. Thefluid housing is adapted to move relative to the applicator from a firsttransit position to a second actuated position to cause penetration ofthe penetrating member with the penetrable wall and to establish thepredetermined coupled relation thereof.

The fluid housing may include an end cap mounted adjacent thepenetrating wall. The end cap preferably defines an open portal topermit the penetrating member to pass therethrough and penetrate thepenetrable wall of the fluid housing upon movement of the fluid housingto the second actuated position. The end cap may include at least oneretaining member mounted along an outer surface thereof. The at leastone retaining member is received within a locking recess associated withthe applicator upon movement of the fluid housing to the second actuatedposition to retain the fluid housing in the second actuated position.The at least one retaining member includes a locking tab which isreceived within a corresponding channel in the dispenser. The lockingtab is adapted to traverse the channel during movement of the fluidhousing to the second actuated position for reception within the lockingrecess. Additional means for retaining the fluid housing in the secondactuated position is also envisioned.

The applicator may include at least two penetrating members. A firstpenetrating member is dimensioned and positioned to penetrate thepenetrable wall in a first location to allow egress of the medical agentfrom the fluid chamber. A second penetrating member of the at least twopenetrating members is dimensioned and positioned to penetrate thepenetrable wall in a second location spaced from the first location toallow air ingress to the fluid chamber. In the alternative, the at leasttwo penetrating members are adapted to divide the penetrable wall intowall portions. The at least two penetrating members may be coaxiallyarranged about an axis in spaced relation. Four penetrating members areprovided to divide the penetrable wall into quadrant portions. In afurther alternative, the penetrating member is arranged in an annulararray of, e.g., a plurality of penetrating members to form asubstantially annular opening within the penetrable wall.

In one preferred embodiment, at least one of the fluid housing and theapplicator includes an internal member. The internal member ispositioned to engage a wall portion defined within the opening of thepenetrable wall to displace the wall portion during movement of thefluid housing to the second actuated position. The internal member is aninternal wall within the fluid housing. The internal wall extends in ageneral longitudinal direction and is positioned to rotate the wallportion of the penetrable wall during movement of the fluid housing tothe second actuated position thereof. Preferably, an internal wall isalso within the applicator. The internal wall extends in a generallongitudinal direction and within the annular array, and is positionedto cooperate with the internal wall of the fluid housing to rotate thepenetrable wall.

The applicator includes an applicator frame and an absorbent membermounted to a lower surface of the applicator frame. The applicatorincludes a relative enlarged section and a relative narrow prow sectiondepending from the enlarged section. The prow section includes opposedgenerally concave surfaces extending to a leading surface whichinterconnects the concave surfaces. The leading surface is preferablyarcuate. The enlarged section includes opposed generally convex surfacesextending from a trailing surface which interconnects the convexsurfaces. Alternatively, the applicator defines a complex curveconfiguration in plan. The complex curve configuration includes a pairof opposed generally convex surfaces and a pair of opposed generallyconcave surfaces extending contiguously from the convex surfaces to aleading surface.

The fluid housing is preferably adapted for longitudinal movement tomove from the first transit position to the second actuated position.The fluid housing may also be adapted for rotational movement relativeto the applicator to release the fluid housing to permit movementthereof toward the second actuated position. One of the fluid housingand the applicator may include a locking tab and the other of the fluidhousing and the applicator include a locking recess for cooperating withthe locking tab to selectively lock the fluid housing and the applicatorin the second actuated position.

An outer housing may be provided for at least partially accommodatingthe fluid housing. The outer housing is mountable to the applicator. Thefluid housing is adapted for longitudinal movement within the outerhousing. A manually engageable member is connected to the fluid housingand extends beyond the outer housing. The manually engageable member isdepressible to cause longitudinal movement of the fluid housing to thesecond actuated position. The manually engageable member may include alocking member which is received within a corresponding locking recessin the outer housing to releasably retain the fluid housing in the firsttransit position. The locking member of the manually engageable membermay include a deflectable tab. The deflectable tab is movable from thelocking recess to release the manually engageable member and permitmovement of the fluid housing to the second position thereof. Means forsecuring the fluid housing in the second position is also provided. Inone arrangement, the outer housing includes a locking recess adapted toreceive the deflectable tab to secure the fluid housing in the secondposition.

In another preferred embodiment, the manually engageable member includesa locking tab releasably mounted thereto. The locking tab selectivelysecures the fluid housing in the first transit position and is removableto permit the manually engageable member to be advanced to move thefluid housing to the second actuated position.

In another preferred embodiment, the applicator frame of the applicatorincludes a conduit for passage of the medical agent from the fluidchamber to the absorbent member. The applicator frame includes aplurality of channels on the lower surface thereof in communication withthe conduit. The channels are dimensioned to convey fluid along thelower surface and to the absorbent member. The applicator frame mayinclude a plurality of arcuate channels defined in the lower surfacethereof and in communication within the conduit for conveying fluid tothe absorbent member. At least two of the arcuate channels are ingeneral concentric arrangement. Alternatively, the channels of theapplicator frame are in intersecting relation. The channels may define ageneral grid pattern on the lower surface of the applicator frame. As afurther alternative, the applicator frame includes first and secondsubstantially linear channels in the lower surface thereof and inintersecting relation, and in communication with the conduit forconveying fluid to the absorbent member.

The applicator frame preferably includes an enlarged opening extendingthrough a lower surface thereof and in communication with the conduit.The opening conveys fluid to the absorbent member. A supplementalchannel may be adjacent the enlarged opening and in communication withthe conduit. The supplemental channel facilitates dispensing of themedical agent. Preferably, first and second supplemental channels areadjacent forward and rear ends of the applicator frame and incommunication with the conduit for facilitating dispensing of themedical fluid. The first and/or second channels may serve as vents forrelease of air captured within the absorbent member.

The absorbent member may include at least one slit defined therein. Theat least one slit is adapted to assume a substantially open conditionupon application of pressure to the absorbent member to permit passageof the medical agent and assume a substantially closed condition in theabsence of pressure to the absorbent member substantially preventing themedical agent to pass therethrough. Preferably, the absorbent memberincludes a plurality of spaced slits. Alternatively, the absorbentmember includes a recessed channel defined in a lower surface thereofadapted to facilitate passage of the medical agent therethrough.

The penetrable wall may include one of a metal and a polymeric memberconnected to the fluid housing. Preferably, the penetrable wall includesa foil liner which is attached to the fluid housing. The foil liner maybe attached to the fluid housing and to the end cap.

In one preferred embodiment, the outer housing and the fluid housing arearranged about a first longitudinal axis and the applicator is arrangedabout a second longitudinal axis displaced from the first longitudinalaxis in a direction perpendicular to the applicator surface. The firstaxis of the fluid housing preferably is in general parallel relation tothe second axis of the applicator.

A dye may positioned relative to the fluid housing. The dye contacts themedical agent upon release of the medical agent from the internalchamber of the fluid housing. The dye may be stored within the fluidhousing in isolated relation from the medical agent whereby uponmovement to the second actuated position, the penetrating memberpenetrates the penetrable wall to permit release of the medical agentand contact thereof with the dye. The fluid housing may include a secondpenetrable wall distal of the first-mentioned penetrable wall and havingthe dye stored therebetween whereby upon movement of the fluid housingto the second actuated position, the penetrating member penetrates thefirst mentioned penetrable wall and the second penetrable wall to permitrespective release of the medical agent and the dye.

In another preferred embodiment, a medical skin applicator apparatusincludes a fluid housing defining a longitudinal axis and having a fluidchamber for storing and selectively releasing a medical agent, and anapplicator coupled to the fluid housing. The applicator includes anapplicator surface in fluid communication with the fluid chamber forapplying the medical agent to a patient. The applicator surface definesa configuration characterized by having a relatively enlarged portionand a relatively narrowed portion extending from the enlarged portion.The relatively narrowed portion includes opposed generally concavesurfaces extending to a leading surface which interconnects the concavesurfaces. The leading surface may be generally arcuate. The enlargedsection includes opposed generally convex surfaces extending from atrailing surface which interconnects the convex surfaces. In thealternative, the applicator defines a complex curve configuration inplan. The complex curve configuration includes a pair of opposedgenerally convex surfaces and a pair of opposed generally concavesurfaces extending contiguously from the convex surfaces to a leadingsurface.

A method of using a medical skin applicator apparatus is also disclosed.The method includes the steps of providing an applicator having a fluidhousing that defines a fluid chamber and an applicator member fordispensing the fluid and actuating the applicator with a single hand tofacilitate fluid communication between the chamber and the applicatormember.

BRIEF DESCRIPTION OF THE DRAWINGS

The objects and features of the present disclosure are set forth withparticularity in the appended claims. The present disclosure, both as toits organization and manner of operation, together with furtherobjectives and advantages, may be best understood by reference to thefollowing description, taken in connection with the accompanyingdrawings, as set forth below, wherein:

FIG. 1 is a perspective view of a medical skin applicator apparatus inaccordance with the principles of the present disclosure illustratingthe fluid container assembly and the applicator head assembly;

FIG. 2 is an exploded perspective view of the skin applicator apparatusof FIG. 1;

FIG. 3 is a side plan view of the skin applicator apparatus illustratingthe fluid container assembly in a first transit position;

FIG. 4 is a side cross-sectional view of the skin applicator apparatus;

FIG. 5 is an enlarged perspective view illustrating the end cap mountedto the fluid housing of the fluid container assembly;

FIG. 6 is an enlarged side plan view illustrating the locking tabs ofthe end cap mounted within axial channels of the applicator headassembly;

FIG. 7 is a perspective view illustrating mounting of the end cap withinthe applicator frame of the applicator head assembly;

FIG. 8 is an enlarged perspective view in cross section illustrating therelationship of the end cap and the penetrating members of theapplicator head assembly;

FIG. 9 is a plan view illustrating the lower surface of the applicatorframe of the applicator head assembly;

FIG. 10 is a plan view illustrating the configuration of the applicatormember of the applicator head assembly;

FIG. 11 is a side plan view similar to the view of FIG. 3 illustratingthe fluid container assembly in a second actuated position;

FIG. 12 is a view similar to the view of FIG. 6 illustrating the lockingtabs of the end cap secured within the locking recesses of theapplicator head assembly when the fluid container assembly is in thesecond actuated position;

FIG. 13 is a view similar to the view of FIG. 8 illustrating thepenetrating members piercing the end cap when the fluid containerassembly is in the second actuated position;

FIG. 14 is a perspective view of the fluid container assemblyillustrating the drainage apertures formed in the liner of the end capwhen in the second actuated position;

FIG. 15 is a perspective view of another embodiment of the skinapplicator apparatus of the present disclosure;

FIG. 16 is an exploded perspective view of the skin applicator apparatusof FIG. 15;

FIG. 17 is a side plan view of the skin applicator apparatus of FIG. 15illustrating the fluid housing assembly in a first transit positionthereof;

FIG. 18 is a side cross-sectional view of the skin applicator apparatusin the first transit position;

FIG. 19 is a perspective view of the end cap;

FIG. 20 is a bottom plan view of the applicator frame of the applicatorhead assembly;

FIG. 21 is a side plan view similar to the view of FIG. 17 illustratingthe fluid housing assembly in a second actuated position thereof;

FIG. 22 is a side plan view of another alternate embodiment of the skinapplicator apparatus of the present disclosure;

FIG. 23 is an exploded view of the skin applicator apparatus of FIG. 22;

FIG. 24 is a side plan view of the skin applicator apparatus in a secondactuated position;

FIG. 25 is a side plan view of another alternate embodiment of the skinapplicator apparatus of the present disclosure illustrating the fluidhousing in the first transit position;

FIG. 26 is an exploded perspective view of the skin applicator apparatusof FIG. 25;

FIG. 27 is a side plan view illustrating rotation of the fluid housingto release the fluid housing from the first transit position;

FIG. 28 is a side plan view of the skin applicator apparatusillustrating the fluid housing in a second actuated position;

FIG. 29 is a perspective view of another alternate embodiment of theskin applicator apparatus of the present disclosure;

FIG. 30 is a side plan view of the skin applicator apparatus of FIG. 29illustrating the fluid container assembly in the first transit position;

FIG. 31 is an exploded perspective view of the skin applicator apparatusof FIG. 29;

FIG. 32 is a side cross-sectional view of the proximal end of the skinapplicator apparatus illustrating the relationship of the locking leverand the release lever of the outer housing and the housing extension;

FIG. 33 is a side cross-sectional view of the distal end of theapplicator apparatus;

FIG. 34 is a side plan view of the fluid housing and the end cap;

FIG. 35 is an axial view of the fluid housing and the end cap;

FIG. 36 is a perspective view in cross-section of the applicator frameand absorbent member of the applicator head assembly;

FIGS. 37-38 are additional perspective views of the applicator frame;

FIG. 39 is a bottom plan view of the applicator apparatus;

FIG. 40 is a side cross-sectional view similar to the view of FIG. 32illustrating release of the locking lever and movement of the housingextension and the fluid housing to the second actuated position;

FIG. 41 is a side cross-sectional view similar to the view of FIG. 33illustrating the relationship of the components subsequent to movementto the second actuated position;

FIG. 42 is a perspective view of the fluid housing and liner subsequentto movement to the second actuated position;

FIG. 43 is an enlarged perspective view of the pierced liner;

FIG. 44 is a side plan view of another alternate embodiment of the skinapplicator apparatus of the present disclosure;

FIG. 45 is a side cross-sectional view illustrating the fluid housing inthe first transit position;

FIG. 46 is a side cross-sectional view illustrating the fluid housing inthe second actuated position;

FIG. 47 is a perspective view of another alternate embodiment of theskin applicator apparatus of the present disclosure;

FIG. 48 is a side cross-sectional view of the skin applicator apparatusof FIG. 47;

FIG. 49 is a partial side cross-sectional view of another embodiment ofthe skin applicator apparatus of the present disclosure;

FIG. 50 is an exploded perspective view of the skin applicator apparatusof FIG. 49;

FIG. 51 is a perspective view in partial cross-section of anotherembodiment of the skin applicator apparatus of the present disclosure;

FIG. 52 is a perspective view of an alternate embodiment of the skinapplicator apparatus of the present disclosure where applicator framehas a circular array of penetrating members;

FIG. 53 is a side cross-sectional view of the skin applicator apparatusof FIG. 52 in the first transit position thereof;

FIG. 54 is a side cross-sectional view of the skin applicator apparatusin the second actuated position;

FIG. 55 is a side plan view of another alternate embodiment of the skinapplicator apparatus of the present disclosure.

FIG. 56 is an exploded perspective view of the skin applicator apparatusof FIG. 55;

FIG. 57 is another plan view of the skin applicator apparatus of FIG.55; and

FIG. 58 is a perspective view of the end cap of the skin applicatorapparatus of FIG. 55.

DETAILED DESCRIPTION OF THE EMBODIMENTS

The exemplary embodiments of the medical skin applicator apparatus anduse(s) thereof are discussed in terms of medical skin applicatorsemployed during medical procedures that involve application ofsterilizing fluids, gels or agents to the skin of a body forpreparation, treatment, etc. The skin applicator apparatus isadvantageously configured to facilitate fluid communication of thesterilizing fluids with a skin contacting member or dispensing member ofthe skin applicator apparatus thereby enabling preparation and treatmentof a skin surface of a patient. It is envisioned that the skinapplicator apparatus may be employed in a range of medical procedures,such as, for example, surgical, diagnostic and related treatments ofdiseases and body ailments of a subject. It is further envisioned thatthe principles relating to the skin applicator apparatus disclosedinclude application of various agents to a body, such as, for example,medications and other fluids.

In the discussion that follows, the term “proximal” will refer to theportion of a structure that is closer to a practitioner, while the term“distal” will refer to the portion that is further from the practitioneror user. As used herein, the term “subject” refers to a human patient orother animal. According to the present disclosure, the term“practitioner” or “user” refers typically to a doctor, nurse or othercare provider and may include support personnel.

The following discussion includes descriptions of the variousembodiments of the skin applicator apparatus in accordance with theprinciples of the present disclosure followed by a description of usesof the apparatus.

Referring now to the drawings wherein like components are designated bylike references throughout the several views, FIGS. 1-3, in conjunctionwith the cross-sectional view of FIG. 4, illustrate the medical skinapplicator apparatus in accordance with the principle of the presentdisclosure. Apparatus 100 includes two main assemblies, namely, fluidcontainer assembly 102 and applicator head assembly 104 which isconnected to the fluid container assembly 102. In general, fluidcontainer assembly 102 is adapted for movement relative to applicatorhead assembly 104 from a first transit position to a second actuatedposition to dispense a medical agent or fluid for application to apatient. Fluid container assembly 102 includes fluid housing 106defining housing axis “x”, and end cap 108 which is releasably mountableto the fluid housing 106. Fluid housing 106 defines internal chamber 106a (FIG. 4) which is filled with a medicant, cleaning solution or thelike. Such medicants are inclusive of antiseptic solutions, sterilizingsolutions, etc., in liquid or in gel form. One suitable sterilizationfluid is the sterilized liquid made under the tradename, Excel-AP,manufactured by Aplicare, Branford Conn. This liquid is comprised of7.5% w/w available Iodine, 64.5% w/w Isopropanol and 25.3% USP sterilewater among other proprietary ingredients.

Fluid housing 106 further defines handle section 110, cylindricalsection 112 disposed distal of the handle section 110 and nipple section114. Handle section 110 has a scalloped undersurface for facilitatinggripping engagement by the user, specifically, with a single hand of theuser. Cylindrical section 112 includes outer circumferential rib 116defined at the juncture of the cylindrical section 112 and handlesection 110. Circumferential 116 serves as a stop to properly positionfluid container assembly 102 relative to applicator head assembly 104upon actuation of apparatus 100. Nipple section 114 incorporatesexternal thread 118.

Fluid housing 106, particularly, handle section 110, may be fabricatedfrom a suitable flexible material to permit the handle section 110 to becompressed to expel the fluid. In one preferred embodiment, fluidhousing 106 is fabricated from a suitable polymeric material such aspolypropylene and is manufactured via conventional injection moldingtechniques. Other elastomeric materials are also envisioned.

Fluid housing 106 also includes a penetrable wall or surface in the formof, e.g., seal or liner 120, connected to the distal end surface ofnipple section 114. Liner 120 may be a metallic or a polymeric material,and is attached to fluid housing 106 subsequent to filling the housing106 with the medical liquid. In one preferred embodiment, liner 120 is afoil liner which is induction sealed to nipple 114 of fluid housing 106.In the alternative, liner 120 may be secured within end cap 108 andadapted to seal nipple 114 when the end cap 108 is mounted to fluidhousing 106. Liner 120 may also be a double ply liner with one plyattached to end cap 108 and the other ply attached to nipple 114. In thealternative, liner 120 may be a spin welded plastic cap having a thinwall which is joined to nipple 114 via a spin weld or the like. Aplastic cap may be required with antiseptic solutions containingalcohol. The plastic cap may have a selected notched geometry thatprovides a fracture point for the sharp point of the penetrating memberto reduce the required puncture bore. Upon actuation of apparatus 100,liner 120 is punctured to permit release of the medical agent or liquidfrom fluid housing 106.

With reference now to FIGS. 4-5, in conjunction with FIG. 2, end cap 108of fluid container assembly 102 will be discussed. End cap 108 isgenerally cylindrical in configuration and defines outer wall 122 andannular flange 124 disposed at the distal end of the outer wall intransverse relation to housing axis “x”. Outer wall 122 incorporates apair of axial guide ribs 126 disposed in diametrically opposed relationand extending along the axis “x” of fluid housing 106. Guide ribs 126orient end cap 108 at a predetermined rotational position relative toapplicator head assembly 104 and/or prevent the end cap 108 fromrotating within applicator head assembly 104 upon assembly. Outer wall122 of end cap 108 further possesses a pair of locking tabs 128 arrangedin diametrical opposed relation approximately 90° displaced from guideribs 126. Locking tabs 128 are each in the shape of a baseball platehaving a leading v-shaped head with angled side surfaces 130 andtransverse surface 132 contiguously extending from the v-shaped head.Locking tabs 128 secure fluid container assembly 102 in the secondactuated position.

Annular flange 124 of end cap 108 defines central opening 132 whichpermits access to liner 120 attached to fluid housing 106. Annual flange124 has peripheral rib 134 disposed about the periphery of the flange124. Peripheral rib 134 extends a predetermined distance along thehousing axis “x” and cooperates with corresponding structure withinapplicator head assembly 102 to form a fluid tight seal within apparatus100 when the apparatus 100 is actuated. End cap 108 further definesinternal thread 136. Internal thread 136 cooperates with external thread118 of fluid housing 106 to mount the end cap 108 to the fluid housing106.

Referring now to FIGS. 2-4, and the enlarged views of FIGS. 6-7,applicator head assembly 104 will be discussed. Applicator head assembly104 includes applicator frame 138 and applicator member 140 (in the formof an absorbent member) which is mounted to the applicator frame 138.Applicator frame 138 incorporates housing support collar 142 at isproximal end and cap support collar 144 disposed distal of the housingsupport collar 142. Housing support collar 142 defines an internalcavity having a diameter which approximates the diameter of cylindricalsection 112 of fluid housing 106 to receive the cylindrical section 112during assembly. Similarly, cap support collar 144 defines an internaldiameter or dimension which corresponds to the diameter of end cap 108.As depicted in FIGS. 6-7, cap support collar 144 further includes atleast one, preferably, a pair of diametrically opposed axial channels146 extending completely through its outer wall and longitudinal reliefslots 148 on opposed sides of each axial channel 146. Axial channel 146is defined by opposed cam surfaces 150 which extend in oblique relationto the housing axis “x” and terminate in locking recess 152. Axialchannels 146 receive locking tabs 128 of end cap 108 and permit thelocking tabs 128 to traverse the channels 146 during actuation ofapparatus 10. The functionality of axial channels 146 and longitudinalslots 148 will be discussed in greater detail hereinbelow.

As best depicted in FIG. 7, cap support collar 144 further definesinternal longitudinal grooves 154. Internal grooves 154 receive axialguide ribs 126 of end cap 108, which traverse the internal grooves 154during actuation of the apparatus 108. Internal grooves 154 and axialguide ribs rotatably fix fluid container assembly 102 within applicatorhead assembly 104. Cap support collar 144 further defines annual groove156 within the internal cavity of the support collar 144. Annual groove156 is arranged in opposed relation to peripheral rib 134 of end cap 108to receive the peripheral rib 134 during actuation of apparatus 100.Annular groove 156 and peripheral rib 134 are appropriately dimensionedto form a seal within the internal cavity of cap support collar 144during actuation of the apparatus to substantially minimize migration offluids back toward fluid housing 106.

Referring now to FIG. 8, applicator frame 138 further defines a pair ofpiercing members or spikes 158 disposed within the interior of capsupport collar 144. Piercing members 158 define sharpened tips whichpenetrate liner 120 during actuation of apparatus 100. Piercing members158 are preferably spaced as shown. Two piercing members 158 are shown,however, it is appreciated that more or less than two piercing members158 may be provided and still achieve the objectives of the presentdisclosure.

Referring now to FIGS. 8-9, applicator frame 138 further includes throat160 and applicator support plate 162 extending from the throat 160.Throat 160 defines internal bore 160 b through which the medical agentor fluid released from fluid housing 106 flows to applicator member 140.Applicator support plate 162 supports applicator member 140. Supportplate 162 includes central aperture 164 which is in communication withinternal bore 160 a of throat 160 and first and second channels 166, 168disposed on the lower surface of the support plate (FIG. 9). Centralaperture 164 is dimensioned to permit a relatively large volume of themedical agent or fluid to be dispersed therefrom and communicatedthrough first and second channels 166, 168. First channel 166 extends ina general longitudinal direction and second channel 168 extends intransverse relation to the first channel 166. First channel 166 definesan enlarged width relative to second channel 168 and permits asufficient volume of medical fluid to communicate with the extreme outerportions, i.e., the leading and trailing ends of, applicator frame 138.Applicator frame 138 may further define a plurality of radial or arcuategrooves 170 generally arranged in the concentric relation shown. Arcuategrooves 170 are in fluid communication with first and second channels166, 168. Arcuate grooves 170 distribute the medical agent tosubstantially the entire surface of support plate 160 for delivery toapplicator member 140. In this regard, the medical agent is uniformlyapplied to applicator member 140 through the fluid manifold definedwithin support plate 162 inclusive of first and second channels 166,168, arcuate grooves 170 and central aperture 164, which consequentlyresults in uniform application to the patient.

Applicator member 140 is mounted to support plate 162. Applicator member140 preferably includes an absorbent member in the form of an open cell,reticulated urethane foam, 75+/−10 pores/inch (ppi). Applicator member140 may be adhered to support plate 160 with adhesives, welding or thelike. Applicator member 140 is configured for transmission of themedical agent dispensed from fluid container assembly 102. The volume ofabsorbent member of applicator member 140 is proportioned to contain thefull contents of the fluid container thereby acting as a fluid reservoirduring application to the patient's skin. This capacity is used tocontrol fluid release and minimize pooling of the antiseptic on thepatient's skin.

As best depicted in FIG. 10 applicator member 140 defines a generaltear-drop shaped or dolphin nosed configuration when viewed in plan. Inparticular, support plate 160 and applicator member 140 define anenlarged section 172 and an elongated neck or prow section 174 dependingfrom the enlarged section 172. Enlarged section 172 is envisioned tofacilitate application of medical fluid to relatively large body areas.Elongated neck section 174 is dimensioned to be-positioned in narrowremote areas such as the patient's fingers, toes, eye area etc. or inareas where only a relatively small amount of fluid is needed. Enlargedsection 172 includes opposed generally convex surfaces 176interconnected by arcuate trailing surface 178. In one preferredembodiment, enlarged section 172 defines a partial ellipse having amaximum width “w” of about 2 inches to about 4 inches. Elongated neck orprow section 174 defines opposed concave surfaces 180 extendingcontiguously from convex surfaces 176 of enlarged section 172, whichlead to leading arcuate surface 182 interconnecting the concave surfaces180. The arcuate configuration of concave surfaces 180 facilitatesmanipulation of apparatus 100 about the fingers, toes, etc. of thepatient. In particular, the curvature of concave services 180 generallyconforms to the curvature of various parts of the anatomy wherebyapplicator member 140 can be applied to the body with the concaveservices 180 being rolled and pivoted in relation to the anatomical bodypart. Prow section 174 defines a minimum width “w₂” of about 0.5 inchesto about 1.5 inches. Absorbent applicator member 140 defines a length“l” ranging from about 3 inches to about 6 inches.

The operation of apparatus 100 now be discussed. In use, thepractitioner grasps applicator 100 with a single hand by anchoring hisor her last three digits to an underside of fluid housing 106. The thumbis then placed across the top of applicator frame 138 to grasp the frame138. The index finger is anchored relative to applicator frame 138, andthen both thumb and index finger are simultaneously pulled toward theanchored fingers to generate a predetermined joining force between fluidcontainer assembly 102 and applicator housing assembly 104. Fluidhousing assembly 102 is thus caused to move relative to applicator headassembly 104 in a longitudinal direction, as depicted by the directionalarrow “z” in FIG. 11 to its second actuated position. The range oflongitudinal movement may be limited by engagement of circumferentialstop or rib 116 with housing supported collar 142.

Referring now to FIG. 12, during axial movement of fluid housing 106,locking tabs 132 of end cap 108 traverse axial channels 146 ofapplicator frame 138. As noted, longitudinal relief slots 148 adjacentaxial channels 146 permits cam surfaces 150 (which define axial channels146) to deflect outwardly through the camming engagement with angledside surfaces 130 of locking tabs 128 whereby the locking tabs 128 arereceived within locking recesses 152. As appreciated, cam surfaces 150provide a degree of resistance to movement of locking tabs 128 throughaxial channels 146. This resistance provides a tactile indicator to thepractitioner of the condition of apparatus 100 thereby minimizing thepotential of inadvertent actuation of the apparatus 100. With lockingtabs 128 received within locking recesses 152, the fluid containerassembly 102 is retained in a second actuated position shown in FIGS.11-13. Simultaneously with the relative advancement fluid housingassembly 102, piercing members 158 of applicator head assembly 104penetrate liner 120 as depicted in FIG. 13. It is also noted that in thesecond actuated position, peripheral rib 134 is received within recess156 (see FIG. 7) to form a substantial fluid tight seal of this locationthereby minimizing fluid back toward fluid housing 106.

Piercing members 158 may be arranged to completely cover liner 120.Alternately piercing member 158 are arranged to puncture two holes inliner 120 as depicted in FIG. 14. The two openings O₁, O₂ produced bythis action produce fluid channels, one for the antiseptic solution tospill into throat of applicator frame 136 under pressure generated bymoderate compression of fluid housing 106 by the practitioner. Secondopening O₂ facilitates fluid disbursement by allowing air to enter fluidhousing 106, thereby equilibrating the internals thereof, preventingvapor lock of the container contents, and providing a more consistentrelease of fluid. The above assembly position is defined as a second or“actuated” position.

Fluid contained within the fluid housing 106 is allowed to flow intoapplicator frame 138 immediately after rupture of liner 120. A moderatecompression of fluid housing 106 allows for a portion of the contentstherein to be evacuated, whereupon release of compression allows for airto replace the contents within fluid housing 106. Allowing for airingress in this manner speeds fluid flow. In this way, fluid can bemetered or pumped out, and within two to three pumps the entire contentsof approximately 60 ml is expelled from fluid housing 106.

With reference to FIGS. 8-9, the fluid migrates to the applicatorsupport plate 162 and is distributed through central apparatus 164 andfirst and second channels 166, 168 and arcuate channels 170. A gentlecompression of fluid housing 106 may force the antiseptic downward intothe pores of absorbent member, e.g. The arrangement of applicator plate162 allows for transfer of the entire container contents to absorbentmember 142 in approximately two to three seconds, i.e., almost instantfluid fill and equilibration, thereby allowing uniform wetting over thesponge's non-symmetrical profile.

In use, the multi-contoured absorbent member 140 conforms tosubstantially all body contours or topology of a patient. For example,prow shaped nose, facilitates prepping of eyes, ears, fingers, toes,groin, or other confined topology. Additionally, the contoured orsection conforms to the radial surface of an arm or leg of a subject.The extended footprint length L (i.e., longer sponge interface) ofapplicator 70 allows for about four times the coverage in a singlestroke by using a side to side motion, as compared with the prior art.This translates into about a four hundred percent increase inproductivity over prior art applicators having flatter contours, whichsaves prepping time and effort, particularly during turnover involvingmultiple surgeries.

As described above, applicator apparatus 100 of the present disclosureincludes key features and advantages not found in the prior art. Thesingle-handed triggering mechanism and single-handed activation improvesease and productivity—there is no snap ring to deal with orpre-triggering mechanism necessary, and there are no other parts thatrequire removal prior to use. Instead, a smooth activation, single snaptriggering mechanism is employed. The minimum number of parts reducescomplexity and manufacturing cost. In addition, fluid housing 106permits for faster wetting, and the integrated fluid manifold within theapplicator frame 138 allows for uniform wetting and balanced fill of anysponge configuration regardless of fluid viscosity. The larger spongeconsequently allows for inverted use of applicator, faster prep andcontrolled fluid release. The contoured multi-use sponge may conform toany patient topology, and the integrated sponge stick/prow provides thedexterity of a conventional sponge stick with the speed of anapplicator.

Referring now to FIGS. 15-18, another preferred embodiment of thepresent disclosure is illustrated. Skin applicator apparatus 200includes fluid container assembly 202 and applicator head assembly 204mounted to the fluid housing assembly 202. Fluid container assembly 202includes fluid housing 206 and collar 208 contiguously extending fromthe fluid housing 206. Fluid housing 206 is preferably in the shape of adome and may incorporate an accordion like configuration to permit thehousing 206 to be compressed to expel the fluid contained therein. It isenvisioned that fluid housing 206 may have various configurations, suchas, for example, cylindrical, rectangular, elliptical, polygon oh, etc.,according to requirements of a particular application. Fluid housing 206may be formed of an elastomeric material or any of the materials definedhereinabove. Fluid container assembly 202 further includes liner 210 andend cap 212 which is mounted to collar 208 of fluid housing 206. Liner210 is preferably in the form of a foil seal and may be adhered tocollar 208 and/or within the interior of end cap 212.

As best depicted in FIG. 19, end cap 212 is devoid of threads and may besecured to collar 208 with adhesives, welding, cements, or the like. Endcap 212 includes a pair of diametrically opposed locking tabs 214 on itsouter surface, preferably, about 180° apart, and axial ribs 216. Lockingtabs and axial ribs 216 function in a similar manner to the locking tabsand axial ribs of the embodiment of FIGS. 1-14.

With reference to FIGS. 16-18, applicator head assembly 204 includesapplicator frame 218 having throat 220 and applicator support plate 222connected to the throat 220. Throat 220 defines internal opening 224which permits passage of the medical agent to support plate 222 and hasproximal flange 226 which is advantageously dimension to be grasped bythe fingers of the practitioner. A pair of axial channels 228 withcorresponding longitudinal relief slots 230 extends within the walls ofthroat 220. Axial channels 228 receive locking tabs 214 and permit thelocking tabs 214 to traverse the channels 228 during actuation of theinstrument. Throat 220 has penetrating spike or member 230 extendingupwardly from applicator supporting plate 222 with internal opening 224.Spike 230 is shown as a single conically shaped element, however spike230 can assume any sharpened configuration or may be multiple in number.

Referring to FIGS. 18 and 20, applicator support plate 222 includes aplurality of apertures 232 in communication with internal opening 224 ofthroat 220, and centrally disposed within the center of applicator plate222. On its lower surface, applicator support plate 222 includes firstand second linear channels 230, 232 in general transverse relation toeach other and centrally located along the major and minor axes “y”, “z”of the support plate 222. Applicator support plate 222 further includesa grid-type arrangement having a plurality of narrow intersectingchannels 234 on its lowest surface and intersecting linear channels 230,232.

In use, fluid container assembly 202 is moved from the first transitposition of FIG. 17 to the second actuated position of FIG. 20.Preferably, the practitioner grabs flange 226 of applicator frame 218with the index and middle finger and positions the palm of his handagainst the upper surface of fluid housing 206. During this movement,locking tabs 214 traverse axial channels 228 and are secured within thelocking recesses 228 a of the axial channels 228 in a manner similar tothat described hereinabove. Concurrently therewith, penetrating member230 pierces liner 210 to permit expulsion of the fluid contained withinfluid housing 206. The fluid then communicates through internal opening224 of throat 220 and apertures 232. The fluid agent then communicatesthrough linear channels 230, 232, and further through the grid typearrangement 234 provided on the lower surface of applicator frame 218.With this arrangement substantially the entire absorbent member 236 issaturated with the medical agent. Apparatus 200 is then utilized toapply the medical agent to the skin of the patient. Fluid housing 206may be compressed to facilitate expulsion of the fluid agent or theagent may be gravity fed by inverting the fluid housing 206.

Referring now to FIGS. 22-24, an alternate embodiment of the presentdisclosure is illustrated. This embodiment is substantially similar tothe embodiment of FIG. 1. However, in accordance with this embodiment,skin applicator apparatus 300 includes fluid housing 302 having a pairof diametrically opposed locking ribs 304 disposed on the exteriorsurface of cylindrical section 306. Locking ribs 304 are generallylinear in configuration and possess enlarged arcuate rib sections 304 aat its distal end. Applicator frame 306 incorporates collar 308 havinglocking channels 310 generally corresponding in shape and position tolocking ribs 304 of fluid housing 302. Specifically, locking channels310 are substantially linear and include first and second arcuatechannel sections 310 a, 310 b. In the first transit position of fluidhousing 302 shown in FIG. 22, each enlarged arcuate rib section 304 a oflocking ribs 304 resides within first arcuate channel section 310 a oflocking channel 310 and is confined therein through the inner boundaryof the channel section 310 a thus releasably securing fluid housing 302in the first transit position. When it is decided to actuate theapparatus 300, the practitioner advances fluid housing 302 relative toapplicator frame 306. During this movement, locking ribs 304 traverselocking channels 310 whereby the surfaces defining the locking channels310 deflect outwardly to permit passage of the enlarged rib section 304a and reception thereof within second arcuate channel section 310 b insnap relation therewith. In this position, locking ribs 304 are securedwithin locking channels 310 thereby securing the fluid housing 302 inthe second actuated position of FIG. 24. In all other respects,apparatus 300 is similar in function to apparatus 100 of FIG. 1.

FIGS. 25-28 illustrate another preferred embodiment of the presentdisclosure. Skin applicator apparatus 400 is generally similar toapparatus 200 described in connection with the embodiment of FIGS. 15.However, in accordance with this embodiment, fluid housing 402 includesat least one or a pair of diametrically opposed locking tabs 404 ondistal collar 406. In this embodiment, apparatus 200 is devoid of an endcap; however, it is envisioned that apparatus 200 may have an end capwith the aforedescribed locking tabs 404. Locking tabs 404 are receivedwithin corresponding generally z-shaped slots 408 defined in throat 410of applicator frame 412. Z-shaped slot 408 is characterized by having afirst vertical section 414, a horizontal section 416 and a secondvertical section 418 extending from the horizontal section 416. Verticalsection 414, 418 includes locking recesses 420, 422. A longitudinalrelief slot 424 is disposed adjacent each vertical section 414, 418 ofz-shaped slots 408. Relief slots 424 permit outward deflection of thewall surfaces defining vertical sections 414, 418 to permit locking tabs404 to be received within locking recesses 420, 422. In use, collar 406of fluid housing 402 is positioned within throat 410 of applicator frame412 with locking tabs 404 positioned within vertical section 414 ofz-shaped slots 408 and received within locking recess 420. In thisposition, fluid housing 402 is retained within applicator frame 412 andreleasably secured in the first transit position through cooperation oftabs 404 with the wall surfaces defining locking recesses 420. When itis decided to actuate apparatus 400, the practitioner rotates fluidhousing 402 in the direction of directional arrow “a” relative toapplicator frame 412 as shown in FIG. 27. Locking tabs 404 are forcedfrom locking recesses 420 whereby relief slots 424 permit the surfacesdefining locking recesses 420 to deflect in an outward direction. Theforce required to displace locking tabs 404 from locking recesses 420provides a tactile indicator to the practitioner of the movement offluid housing 402 toward the second actuated position. Locking tabs 404traverse horizontal sections 416 of the z-shaped slot 408 to a positionin alignment with second vertical section 418, shown in FIG. 27.Thereafter, the practitioner applies a distal force to fluid housing 402to cause the fluid housing 402 to advance relative to applicator frame412 to the position depicted in FIG. 28. During this movement, lockingtabs 404 traverse second vertical section 418 of the shaped slot 408 andare received within the locking recesses 422. As appreciated, duringthis movement wall surfaces defining vertical section 418 are permittedto deflect outwardly by provision of longitudinal relief slots 424 topermit locking tabs 404 to be received within locking recesses 422.Locking recesses 422 thus retain locking tabs 404 to thereby retainfluid housing 402 in its second actuated position dispensing the medicalagent into absorbent member 426.

Referring now to FIGS. 29-31, there is illustrated another alternativeembodiment of the skin applicator apparatus of the present disclosure.Skin applicator apparatus 500 includes fluid container assembly 502 andapplicator head assembly 504 connected to the fluid container assembly502. Fluid container assembly 502 includes fluid housing 506, end cap508 connected to the housing 506 and liner 510. Fluid housing 506includes at least one cylindrical locking protrusion 512 or,alternatively, a pair of locking protrusions 512 which extends radiallyoutwardly relative to housing axis “x”, and circumferential rib 514distal of the locking protrusion(s) 512. Fluid housing 506 furtherincludes external thread 516 at its distal end and a plurality ofradially spaced wings 518 extending outwardly from the wall of fluidhousing 506 proximal of thread 516. Liner 510 is preferably a foilliner, and may be secured to fluid housing 506 through any of theafore-mentioned means. End cap 508 includes internal thread 520 whichcooperates with external thread 516 of fluid housing 506 to secure theend cap 508 onto the fluid housing 506 (FIG. 33). End cap 508 furtherincludes a plurality of angled teeth 519 at the mouth of the end cap(FIG. 31 and FIG. 35). In the secured position, radially spaced wings518 on the exterior surface of fluid housing 506 engage or bite into theangled teeth 519 of end cap 508 to prevent the end cap 508 frominadvertent removal from the fluid housing 506 (FIG. 35). End cap 508further defines a distal collar section 508 c having a reduceddiameter—the function of which will be discussed in greater detailhereinbelow.

Referring again to FIGS. 30-32, fluid container assembly 502 furtherincludes housing extension 522 which is connected to fluid housing 506.In one preferred method of attachment, housing extension 522 includes apair of cylindrical openings 524 through its wall for reception oflocking protrusions 512 of fluid housing 506 in snap relation therewith.Other means for connecting housing extension 522 to fluid housing 506are also envisioned. Housing extension 522 further includes lockinglever 526 in its outer wall. Locking lever 526 is adapted to releasablyretain fluid housing 506 in the first unactuated position. Locking lever526 defines locking shelf 528 and is adapted to deflect radiallyinwardly along its living hinge to release the locking shelf 528 as willbe discussed. Housing extension 522 further defines manually engageablebutton 530 at its proximal end. Button 530 defines a reduced diameterrelative to the remaining portion of housing extension 522 and has arail 532 extending in an axial direction along its outer surface. Rail532 ensures a single alignment position to facilitate assembly.

Skin applicator apparatus 500 further includes outer housing 534. Outerhousing 534 is secured to applicator head assembly 504 and isdimensioned to accommodate fluid housing 506 and housing extension 522.Outer housing 534 defines a contoured configuration having a pluralityof spaced ribs 536 on its outer surface to facilitate grippingengagement by the practitioner. Outer housing 534 defines centralaperture 538 at its proximal end which receives manually engageablebutton 530 of housing extension 522, and keyed opening 540 for receivingrail 532 of the housing extension 522 (FIG. 31). With this relationship,housing extension 522 is adapted to move in a general longitudinaldirection relative to outer housing 534, but, is rotatably fixedrelative to the outer housing 534.

Outer housing 534 further defines opening 542 (FIG. 31) in its outerwall for at least partially accommodating locking lever 526 of housingextension 522. Opening 542 defines distal locking surface 544 which isengaged by locking shelf 528 of locking lever 526 of housing extension522 when in the first transit position of fluid housing 506 (FIG. 32).Outer housing 534 incorporates release lever 546 which extends withinopening 542 of the outer housing 534 in superposed relation to lockinglever 526 of housing extension 522. Release lever 546 pivots radiallyinwardly about its living hinge to engage and cause correspondingpivotal movement of locking lever 526 to release locking shelf 528 fromits engagement with locking surface 544. In this orientation, housingextension 522 and fluid housing 506 are permitted to move in alongitudinal direction to the second actuated position.

Referring now to FIGS. 33 and 36-38, applicator head assembly 504 willbe discussed. Applicator head assembly 504 includes applicator frame 548and absorbent applicator member 550 attached to the applicator frame548. Applicator frame 548 includes throat 552 defining an internal borefor reception of end cap 508 and fluid housing 506. Throat 552 has atleast one opening 552 a (FIG. 31) in its outer wall for accommodating acorresponding locking projection 554 of outer housing 534 to fixedlysecure applicator frame 548 to the outer housing 534.

As best depicted in FIGS. 33, 36-37, within the interior of throat 552is internal collar 556 mounted to transverse wall 557, and a pluralityof penetrating members 558 extending from the internal collar 556.Penetrating members 558 are preferably four in number and are arrangedalong intersecting planes to define four quadrants when the penetratingmembers 558 pierce liner 510. More or less than four penetrating members558 are also envisioned. Specifically, each penetrating member 558extends to a point 560 with each of the points 560 of the penetratingmembers 558 being disposed about a central axis “c” in adjacent spacedrelation as shown.

Referring now to FIGS. 36-38, applicator frame 548 further defines firstand second channels 562, 564 disposed about the periphery of internalcollar 556 adjacent upper and lower areas of throat 552. First andsecond channels or manifolds 562,564 facilitate passage of the medicalagent or fluid directly to the leading and trailing ends, respectively,of applicator member 550. First channel 562 is generally semicircular incross-section and extends from semicircular passage 562 a adjacent theperiphery of internal collar 556 to the upper or forward end ofapplicator frame 548. Second channel 564 extends from an arcuate orcrescent shape opening 564 a within transverse wall 557 and is incommunication with the lower or rear end of applicator frame 548.Applicator frame 548 further defines central enlarged orifice 566 whichextends to the lower surface of applicator frame 548. Orifice 566 is influid communication with first and second channels 562, 564, and issized to expel a substantial volume of fluid onto the central area ofabsorbent member 550.

Referring now to FIGS. 36 and 39, absorbent member 550 is substantiallysimilar in shape to the absorbent members discussed hereinabove and ispreferably in the form of an absorbent sponge, foam, etc. Absorbentmember 550 is mounted to the lower surface of applicator frame 548 viaconventional means. Absorbent member 550 includes a plurality of spacedslits 568 which extend completely through the thickness of the absorbentmember 550 along the central axis of absorbent member 550. Slits 568function as zero closure valves, i.e. the slits 568 are adapted toremain closed in the absence of pressure to absorbent member 550 butwill open when pressure is applied to the absorbent member 550 to permitthe fluid to flow therethrough.

In use, the practitioner grabs apparatus 500 with a single handpreferably about outer housing 534. Thereafter, to activate apparatus500, the practitioner engages release lever 546 of outer housing 534 anddepresses the release lever 546 in a radially inward direction “i” asdepicted in FIG. 32. Release lever 546 pivots about its living hinge toengage locking lever 526 of housing extension 522 to cause correspondinginward movement of the locking lever 526. As locking lever 526 pivotsinwardly, locking shelf 528 of locking lever 526 is released from itsengagement with locking surface 544 of outer housing 534. In thisposition, housing extension 522 and fluid housing 506 are free to movein the longitudinal direction.

Referring now to FIG. 40, the practitioner thereafter advances button530 at the proximal end of housing extension 522 with the heel of hishand or, alternatively, with the thumb of the practitioner. Theactivation force required (approximately 8-12 lbs makes it possible tothumb activate if desired) to advance housing extension 522 and fluidhousing 506 in a distal direction relative to outer housing 534 andapplicator head assembly 504 (FIG. 41). With particular reference now toFIG. 42-43, distal direction of fluid housing 506 causes liner 510 to bepenetrated by the four penetrating members 558 which results in theliner 510 being pierced into four quadrants portions 510 a-d. The strokeinvolved allows the foil to be stripped over the sidewall of thepiercing cylinder thereby providing the full diameter for fluid flow.Upon rupture of liner 510, the medical agent within fluid housing 506 isexpelled almost instantaneously through internal bore of internal collar556 and into first and second channels 562, 564 for dispensing withinenlarged orifice 566 of applicator frame 548. Enlarged orifice 566 is ofsubstantial dimension such that the cohesive force associated with themedical agent is overcome by the mass of the fluid. This allows thefluid to “tumble out” in seconds via gravitational forces, i.e., nocompression of the fluid housing is necessary. In addition, firstchannel 562 directs fluid to the elongated neck section of applicatormember and second channel 564 directs fluid to the rear area. In thismanner, a uniform layer of fluid is distributed to the absorbent member550. Furthermore, first and/or second channels 562, 564 may establish anequilibrium within applicator frame 548 by permitting air to pass withinthe interior of applicator frame 548 thus ensuring a sufficient flow ofthe medical agent. Preferably, either or both of first and secondchannels 562, 564 may provide a vent permitting the air displaced duringcompression of absorbent member 550 to be directed back through channels562, 564 through respective openings or passages 562 a, 564 a and intoapplicator frame 548 for venting to the atmosphere. FIG. 33 illustratesthe manner in which first channel 562 extends through passage 562 aabout collar 556 and communicates with the interior of applicator frame548. The assembly tolerance associated with the components of apparatus500 is sufficient to permit the air to vent. Furthermore, in theactuated position, distal collar 508 c of end cap 508 hermetically sealsabout the outer surface of internal collar 556 to prevent leakage towardthe proximal end of the applicator frame (see FIG. 41). This arrangementmay also serve as a friction fit or interference fit which retains fluidhousing in the second actuated position. A volume of medical agent maypass back through passage 562 a or opening 564 a of transverse wall 557during compression of absorbent member 550 to accommodate volumetricdisplacement of the fluid. It is further noted that fluid housing 506may be retained in the second actuation position by engagement oflocking shield 528 of locking lever 526 with a corresponding positionlocking aperture 570 within the outer wall of outer housing 534 (seee.g., FIG. 40).

As described above, the applicator apparatus of the present disclosureincludes key features and advantages not found in the prior art. Whereasthe prior art requires two-handed use and high force activation, thepresent disclosure provides single-handed triggering and lightactivation pressure similar to activating a click-pen. This results inless hand fatigue and no “smacking” is required. Neither a snap ring nora high activation force is required to prevent misfire, and no partsrequire removal prior to use. Instead, a single step, squeeze-to-releaseshipping lock prevents unintended activation, and the minimum number ofparts reduces complexity and manufacturing cost. In addition, prior artapplicator handles are smooth, straight, and angled at 45 degrees,resulting in limited comfort and control. In contrast, the ergonomichandle of the present disclosure is ribbed for comfort and traction evenwhen wet. The handle's hourglass contour and rounded end accommodate anysize hands, and a reduced handle angle between 30-40 and preferably 35degrees permits greater access and control. While the prior art includesrestrictive conduits or mesh to retard fluid transfer, the wide mouthbottle of the present disclosure allows the mass of antiseptic toovercome surface tension and to drain rapidly to the absorbent member.The bottle contents evacuation is also speeded by the double piercingmeans which creates air ingress over the fluid layer in the fluidhousing. Prior art sponges are shaped symmetrically to compensate forlack of manifolds. In contrast, the “c channel” manifolds of the presentdisclosure uniformly wet opposing ends of the asymmetric sponge. Whileprior art devices work poorly when inverted due to small sponge capacityand slow fluid transfer, the present disclosure provides for inverteduse and faster prep since the large sponge acts as a reservoir forrapidly transferred fluid. The prior art includes a square sponge headand performs poorly on contoured topology. However, the contouredmulti-use sponge conforms to any patient topology, and the integratedsponge neck region provides the dexterity of a conventional sponge stickwith the speed of an applicator. The sponge has a thickness T that istwice the thickness of the prior art, which inures less risk injury topatient, and the longer sponge length L allows for faster prep.

The components of medical skin applicator apparatus may be fabricatedfrom materials suitable for medical applications, such as, for example,polymerics or metals, such as stainless steel, depending on theparticular application and/or preference of a practitioner. Semi-rigidand rigid polymerics are contemplated for fabrication, as well asresilient materials, such as molded medical grade polypropylene. Oneskilled in the art, however, will realize that other materials andfabrication methods suitable for assembly and manufacture, in accordancewith the present disclosure, also would be appropriate.

FIGS. 44-46 illustrate an alternate embodiment of the presentdisclosure. In accordance with this embodiment, skin applicatorapparatus 600 incorporates an alternate mechanism to releasably securethe fluid container assembly in the first transit position. Inparticular, housing extension 602 includes a pair of outercircumferential partial ribs 604 in diametrically opposed relation onthe outer surface of button 606. Ribs 604 reside beyond outer housing608 in the first transit position of fluid housing 610 depicted in FIGS.44-45. Outer housing 608 defines a restricted opening 612 at itsproximal end, which has an internal dimension or diameter less than theeffective cross-sectional dimension of housing extension 602 across andinclusive of partial ribs 604. Thus, partial ribs 604 prevent passage ofhousing extension 602 through opening 612 of outer housing 608. When itis decided that apparatus 600 will be actuated, the practitioner exertsa distal pressure to button 606 of housing extension 602 which causespartial ribs 604 and/or the respective walls of housing extension 602and outer housing 608 to flex, deform, etc. to permit passage of thepartial ribs 604 through the restricted opening 612 thereby enablingfluid housing 610 to move to its second actuated position depicted inFIG. 46. It is further envisioned that housing extension 602 may besecured in the second actuated position through the provision ofinternal locking tabs or recesses within outer housing 608. The internaltabs or recesses may be appropriately dimensioned to engage, receive,the partial ribs 604 in a secured relation. Absorbent member 614includes a plurality of openings 616 extending completely through itsthickness as disclosed in FIG. 45. Openings 616 replace the slits ofprior embodiments

Another feature of applicator apparatus 600 and apparatus 500 of FIG. 44is the arrangement of the handle component relative to applicator headassembly. In particular, the handle components of these apparatuses aredisplaced relative to the applicator head assembly which facilitatesmanipulation of the apparatuses about the operative site. In particular,outer housing 608 and the internal components forming the fluidcontainer assembly are arranged along a handle axis “j” as shown in FIG.44. Applicator head assembly 620 including applicator frame 622 iscoaxially arranged about axis “k”. As appreciated axis “k” is verticallydisplaced relative to axis “j” by a predetermined distance but ispreferably in parallel relation. This offset allow the practitioner tomaintain the most preferred 35 degree relationship with the patientwhile allowing for additional clearance due to this offset therebymaintaining a “comfort zone” in relation to the patient's skin, e.g.,the practitioner's hand is displaced from the patient to enhancemaneuverability around the operation site.

FIGS. 47-48 illustrate another alternate embodiment of the skinapplicator apparatus of the present disclosure. In accordance with thisembodiment, skin applicator apparatus 700 is releasably secured in itstransit position via detachable tag 702. In particular, housingextension 704 attached to fluid housing 706 includes transverse bore 708within manually engageable button 710. Releasable tag 702 is positionedwithin transverse bore 708 and when positioned within the bore 708prevents advancement of housing extension 704 and attached fluid housing(not shown) thereby releasably securing apparatus 700 in the firsttransit position. Releasable tag 702 may be removed from transverse bore708 to permit activation of the apparatus and movement of the fluidcontainer assembly to the second actuated position. Releasable tab 702may be fabricated from any solid or flexible material and preferablyincorporates handle 712 to facilitate grasping by the practitioner.Absorbent member 714 of the applicator head assembly preferableincorporates longitudinal channel 716 in its lower surface to provide agreater volume of fluid flow. Channel 716 may be in connection withslots or openings extending through the absorbent member 714.

FIGS. 49-50 illustrate another alternate embodiment of the presentdisclosure useful for dispensing clear antiseptics such as ChlorhexidineGluconate/Alcohol solutions. Clear antiseptics pose a problem topractitioners since it is difficult to verify the area of coverage afterapplication. Skin applicator apparatus 800 is substantially similar tothe skin applicator apparatus discussed in connection with FIG. 29 butfurther includes a dye chamber for introducing a dye or coloring agentto the medical agent or fluid. Specifically, fluid housing 802 has foilliner 804 connected thereto as discussed hereinabove and first end cap806 threadably mounted to the housing 802. Apparatus 800 furtherincludes second end cap 808 mounted to first end cap 806. In onepreferred arrangement, first end cap 806 includes external threads 810and second end cap 808 includes corresponding internal threads 812 whichthreadably engage the external threads 810 to secure the second end cap808 to the first end cap 806. Second end cap 808 also includes foilliner 814 secured within the interior of the end cap. In the mountedcondition of second end cap 808 to first end cap 806, a chamber 816 isdefined between the respective foil liners 814, 804 of the twocomponents. A dye or coloring agent 818 is stored within chamber 816. Asuitable dye is FD&C green #3 dye manufactured by Parchem Trading Ltd.White Plains, N.Y. 10601. During actuation of the apparatus, thepenetrating members 820 of applicator frame 822 pierce both liners 814,804 whereby the dye 818 within chamber 816 mixes with the medical agentduring passage through applicator frame 822. The dye thus colors themedical agent or antiseptic to a desired color.

FIG. 51 illustrates an alternate embodiment in which a dye tablet 850 ispositioned within applicator frame 822. Preferably, the tablet 850containing the dye is positioned within internal conduit 854 adjacentabsorbent member 856. The dye tablet is contacted by the medical agentas it is transferred to the absorbent member 856. The dye tablet may becomposed of the dye discussed in connection with the embodiment of FIGS.49-50.

FIGS. 52-54 illustrate another alternate embodiment of the presentdisclosure. Skin applicator apparatus 900 includes an alternatemechanism for severing the foil liner. The mechanism is preferably inthe form of a circular array of penetrating members or spikes 902extending from internal collar 904 of applicator frame 906 which isshown in perspective view in FIG. 52. This circular array is adapted toform a general circular opening within foil liner 908 attached to fluidhousing 910. In further accordance with this embodiment, fluid housing910 is provided with an internal dividing wall 912 extending in ageneral longitudinal direction. Similarly, internal collar 904 may beprovided with longitudinal wall 914. Internal walls 912,914 serve toengage and rotate the wall portion of foil liner 908 severed by thecircular array of penetrating members 902 from its original transverseposition to a rotated position in general alignment with thelongitudinal axis (as shown in FIG. 54) upon movement of fluid housing910 to the second position of FIG. 54. In this position, the medicalagent can flow in an unrestricted manner through applicator frame 906unimpeded by the severed foil liner 908. Preferably, the internal walls912, 914 within fluid housing 910 and internal collar 904 of applicatorframe 906 are radially displaced or longitudinally misaligned such thatthe severed wall portion of the foil liner is trapped between the twowalls 912,914 upon movement to the second actuated position. In otherrespects, this embodiment functions in a similar manner to the priorembodiment of FIG. 29.

Referring now to 55-58, an alternative embodiment in accordance with theprincipals of the present disclosure is disclosed. Skin applicatorapparatus 1000 includes fluid container assembly 1002 which is tetheredto the applicator 1004 through a tether line 1006. More specifically,fluid container assembly 1002 includes fluid housing 1008, foil liner1010 and end cap 1012 which is threadably mounted to fluid housing 1008.End cap 1012 includes internal thread 1014 which threadably engagesexternal thread 1016 (FIG. 58) of fluid housing 1008. Applicator 1004includes O-ring connector 1018 to which tether 1006 is connected. O-ringconnector 1018 is positioned over the neck 1020 of end cap 1012 andretainer therein by circumferential rib 1022 on the exterior of the neck1020. Applicator 1004 incorporates a circumferential array ofpenetrating members 1024 similar to the array discussed in the priorembodiment for piercing liner 1010. Applicator 1004 incorporates aplurality of spaced bulbous applicator tip 1026 with a plurality ofspaced openings 1028 for dispensing the medical agent. A circularabsorbent sponge 1030 may be mounted onto applicator tip 1026. In use,applicator 1004 can be pivoted onto assembly 1002 and secured to thefluid container 1002 through reception of circumferential rib 1022 withannular recess 1032 within applicator 1004. Other means are alsoenvisioned including an interference fit, snap fit, bayonet coupling orthe like. Mounting of the applicator 1004 causes the spikes to penetratethe liner thereby activating the apparatus 1000.

It will be understood that various modifications and changes in form anddetail may be made to the embodiments of the present disclosure withoutdeparting from the spirit and scope of the invention. Therefore, theabove description should not be construed as limiting the invention butmerely as exemplifications of preferred embodiments thereof. Thoseskilled in the art will envision other modifications within the scopeand spirit of the present invention as defined by the claims appendedhereto. Having thus described the invention with the details andparticularity required by the patent laws, what is claimed and desiredprotected is set forth in the appended claims.

1-65. (canceled)
 66. A medical skin applicator apparatus, whichcomprises: a fluid housing having a fluid chamber for storing andselectively releasing a medical agent; and an applicator head coupled tothe fluid housing and having an applicator member mounted thereto, theapplicator member being adapted to dispense the medical agent whenreleased from the fluid chamber of the fluid housing, the applicatormember defining a longitudinal axis extending along a length of theapplicator member and, defining in plan, from a leading end to atrailing end: an outer leading surface; opposed outer first surfacesextending along the longitudinal axis from the leading surface, thefirst surfaces being generally concave; opposed outer second surfacesextending along the longitudinal axis from the first surfaces; and atrailing surface interconnecting the second surfaces.
 67. The medicalskin applicator apparatus according to claim 66 wherein the secondsurfaces are generally convex.
 68. The medical skin applicator apparatusaccording to claim 67 wherein the second surfaces are dimensioned andarranged to contiguously extend from the first surfaces.
 69. The medicalskin applicator apparatus according to claim 68 wherein the firstsurfaces are dimensioned and arranged to contiguously extend from theleading surface.
 70. The medical skin applicator apparatus according toclaim 69 wherein the trailing surface is contiguous with the secondsurfaces.
 71. The medical skin applicator apparatus according to claim69 wherein the leading surface is one of a generally arcuate orgenerally convex surface.
 72. The medical skin applicator apparatusaccording to claim 71 wherein the trailing surface is one of a generallyarcuate or generally convex surface.
 73. The medical skin applicatorapparatus according to claim 72 wherein the applicator member defines arelatively narrowed portion having a first maximum width transverse tothe longitudinal axis and which includes the first surfaces and arelatively enlarged portion which includes the second surfaces, thenarrowed portion having a first maximum width transverse to thelongitudinal axis and the enlarged portion having a second maximum widthtransverse to the longitudinal axis and substantially greater than thefirst width.
 74. The medical skin applicator apparatus according toclaim 73 wherein the ratio of the second width to the first width is atleast 3.5:1.0.
 75. The medical skin applicator apparatus according toclaim 66 further including an outer housing defining a longitudinalaxis, the fluid housing being at least partially disposed within theouter housing, the fluid housing having a penetrable wall to permitaccess to the fluid chamber and release of the medical agent therefrom.76. The medical skin applicator apparatus according to claim 75 whereinthe applicator head includes an applicator frame, the applicator framebeing mounted to the outer housing in longitudinal fixed relationtherewith, the applicator frame having an internal penetrating memberdimensioned to penetrate the penetrable wall of the fluid housing, thefluid housing being adapted for longitudinal movement relative to theapplicator frame and within the outer housing from a first transitcondition to a second actuated condition to cause penetration of thepenetrable wall with the penetrating member to thereby permit themedical agent to be dispensed from the fluid chamber and applied to thepatient with the applicator member.
 77. The medical skin applicatorapparatus according to claim 76 further including a manually engageablemember operatively coupled to the fluid housing and extending beyond theouter housing, the manually engageable member being depressible viamanual manipulation to cause longitudinal movement of the fluid housingto the second actuated position.
 78. The medical skin applicatorapparatus according to claim 76 wherein the applicator frame includes aconduit for passage of the medical agent from the fluid chamber to theapplicator member.
 79. The medical skin applicator apparatus accordingto claim 78 wherein the applicator frame includes a plurality ofchannels in communication with the conduit, the channels for conveyingfluid along the lower surface and to the applicator member.
 80. Themedical skin applicator apparatus according to claim 79 wherein theapplicator frame includes a plurality of arcuate channels defined in thelower surface thereof and in communication within the conduit forconveying fluid to the applicator member.
 81. The medical skinapplicator apparatus according to claim 79 wherein at least two of thearcuate channels are in general concentric arrangement.
 82. The medicalskin applicator apparatus according to claim 79 wherein the channels ofthe applicator frame arc in intersecting relation.
 83. The medical skinapplicator apparatus according to claim 82 wherein the channels define ageneral grid pattern on the lower surface of the applicator frame. 84.The medical skin applicator apparatus according to claim 82 wherein theapplicator frame includes first and second substantially linear channelsin the lower surface thereof and in intersecting relation, and incommunication with the conduit for conveying fluid to the absorbentmember.
 85. The medical skin applicator apparatus according to claim 84wherein the applicator frame includes a plurality of arcuate channels inthe lower surface thereof and in fluid communication with the linearchannels.